BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2212669 · Received August 10, 2011

    Report

    Report Number
    3003681312-2011-00058
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES.

    Description of Event or Problem · 1

    IT WAS REPORTED A CORONARY DIAGNOSTIC PROCEDURE WAS PERFORMED AND AN ANGIO-SEAL WAS DEPLOYED VIA THE RIGHT FEMORAL ARTERIOTOMY, HEMOSTASIS WAS ACHIEVED. A FEW HOURS AFTER THE PROCEDURE, BLEEDING FROM THE PUNCTURE SITE WAS OBSERVED AND THE PATIENT'S HEMOGLOBIN DROPPED. A BLOOD-TRANSFUSION WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT AND WAS REPORTED TO BE RECOVERING. THE PATIENT'S TROPONIN LEVEL WAS REPORTED AS HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 3344268

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R